Using high-intensity focused ultrasound to treat basal cell carcinoma
High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.
This study is testing a new device that uses high-intensity focused ultrasound to see if it can safely and effectively treat basal cell carcinoma while protecting healthy skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 2 sites (Copenhagen, Hovedstaden and 1 other locations) |
| Trial ID | NCT05133427 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of a new investigational device that utilizes high-intensity focused ultrasound (HIFU) to treat basal cell carcinoma (BCC). The device is designed to target and destroy BCC cells while minimizing damage to surrounding healthy tissue. Participants will include individuals with newly diagnosed non-nodular BCC or recurrent BCC that has been previously treated. The study will involve monitoring the treatment outcomes and any potential side effects associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed non-nodular or recurrent basal cell carcinoma.
Not a fit: Patients with nodular basal cell carcinoma or those with tumors thicker than 2.0 mm will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive and more effective option for patients with basal cell carcinoma.
How similar studies have performed: While the use of HIFU for skin cancers is emerging, this specific approach for basal cell carcinoma is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age. * Subjects who have received oral and written study information, accepted participation and signed the informed consent document. * Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions. * Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications. * Subjects, who have histologically and clinically verified basal cell carcinoma either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included. Exclusion Criteria: * Subjects who are less than 18 years at the time of informed consent. * Subject is pregnant or lactating at time of first treatment * Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure. * Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons * Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer. * Any condition predisposing to treatment-related adverse effects or complications from the ultrasound treatment. * Subjects with abnormal scar formation * Subjects with impaired wound healing * Subjects with the basal cell carcinoma under study located nearby (\<5 cm) an implant or a site injected with a dermal filler or paraffin. * Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.
Where this trial is running
Copenhagen, Hovedstaden and 1 other locations
- Bispebjerg Hospital — Copenhagen, Hovedstaden, Denmark (Recruiting)
- Roskilde Hospital — Roskilde, Sjaelland, Denmark (Recruiting)
Study contacts
- Study coordinator: Joergen V Serup, Professor
- Email: Joergen.Vedelskov.Serup@regionh.dk
- Phone: +45-2142 4888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.